The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Sequana Medical announces Annual General Meeting of Shareholders on 23 May 2019

Regulated Information

Ghent, BELGIUM – 23 April 2019 (18:00 CEST) Sequana Medical NV (“Sequana Medical” or the “Company“) (Euronext Brussels: SEQUA), a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders, announces that its Annual General Meeting of Shareholders will be held on Thursday, 23 May 2019.

The items on the agenda of the Annual General Meeting of Shareholders include the proposed approval of a number of resolutions relating to the financial year ended 31 December 2018 as well as the appointment of Mr. Jason Hannon as independent non-executive director of the Company.

The Annual General Meeting of Shareholders will take place at the Company’s registered offices in Ghent, Belgium, and will start at 09:00 CEST. The full convening notice with the agenda and proposed resolutions can be accessed on the Company’s website: www.sequanamedical.com/investors/shareholder-information.


For more information, please contact:

Sequana Medical

Lies Vanneste

Director IR

Tel: +32 (0) 498 05 35 79

Email: IR@sequanamedical.com


Consilium Strategic Communications

Alexandra Harrison, Marieke Vermeersch, Sukaina Virji

Tel: +44 (0) 203 709 5000

Email: sequanamedical@consilium-comms.com


About Sequana Medical

Sequana Medical is a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders.

Sequana Medical’s technology is based on its proprietary alfapump® platform, a fully implantable, programmable, wirelessly-charged, battery-powered system for automatic and continuous removal of fluid from the abdomen, which is applicable across multiple life-threatening disorders. The alfapump is being commercialised in Europe for the management of refractory ascites (chronic fluid build-up in the abdomen) due to liver cirrhosis and malignant ascites. The number of patients with refractory liver ascites is forecast to increase dramatically due to the growing prevalence of NASH (Non-alcoholic Steatohepatitis).

Over 700 alfapump systems have been implanted to date and since April 2018, the alfapump has been included in the EASL (European Association for the Study of the Liver) clinical practice guidelines for decompensated cirrhosis. In January 2019, the FDA has granted Breakthrough Device designation for the alfapump for the treatment of recurrent or refractory liver ascites. The alfapump has not yet received regulatory approval in the U.S. and Canada and the Company expects to start POSEIDON, the North American pivotal study in in the second half of 2019 to support approval of the alfapump in recurrent or refractory liver ascites.

The alfapump is one of the first safe and effective, long-term alternatives to large-volume paracentesis (LVP) for the management of ascites, offering major advantages to patients, clinicians and healthcare systems. By automatically and continuously moving ascites to the bladder, where the body eliminates it naturally through urination, the alfapump prevents fluid build-up and its possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfapump DirectLink technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfapump.

Sequana Medical is developing the alfapump DSR, built upon the proven alfapump platform, to deliver a convenient and fully implanted system for Direct Sodium Removal (DSR) therapy, a novel and proprietary approach for the management of volume overload in heart failure. A first-in-human study for DSR therapy is ongoing. Treatment of volume overload in diuretic-resistant heart failure patients is a major clinical challenge. There are an estimated one million hospitalisations due to heart failure in the U.S. each year, of which 90% are due to symptoms of volume overload. The estimated cost of heart failure-related hospitalisations in the U.S. is $13 billion a year.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.


Important Regulatory Disclaimer

Any statement in this press release about safety and efficacy of the alfapump does not apply to the U.S. and Canada because the device is currently undergoing clinical investigation in these territories.


Download the full press release

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